Severance Hospital
Seoul, South Korea
NCT Number: NCT01842230
The purpose of this study is to investigate the effect of Atorvastatin on the pharmacokinetic properties of Telmisartan/S-amlodipine
Looking for future studies?
Notify Me20 year–45 year
All sexes
Interventional
Phase 1
Seoul, South Korea
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
5.If men has sexual life with women of childbearing age, Necessarily he agrees that use condoms during clinical trials and do not sperm donation during clinical trials and until one month after the final dosage of investigational products 6.Those who fully understand about this clinical trial after enough hearing, and then decided to join the clinical trials by themselves and to comply with the precautions written consent.
Exclusion criteria
Time frame: Telmisartan: Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 8, 12, 24, 36, 48hr post-dose, S-amlodipine:Pre-dose, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72, 96, 120, 144, 168hr post-dose
AUClast = Area under the plasma concentration-time curve from zero time until the last measurable concentration
Time frame: Telmisartan: Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 8, 12, 24, 36, 48hr post-dose, S-amlodipine: Pre-dose, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72, 96, 120, 144, 168hr post-dose
Cmax=Maximum Plasma Drug Concentration
Time frame: Telmisartan: Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 8, 12, 24, 36, 48hr post-dose, S-amlodipine:Pre-dose, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72, 96, 120, 144, 168hr post-dose
AUCinf=Area under the plasma concentration-time curve from time zero to infinity
Time frame: Telmisartan: Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 8, 12, 24, 36, 48hr post-dose, S-amlodipine:Pre-dose, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72, 96, 120, 144, 168hr post-dose
Tmax=Time to Cmax
Time frame: Telmisartan: Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 8, 12, 24, 36, 48hr post-dose, S-amlodipine:Pre-dose, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72, 96, 120, 144, 168hr post-dose
T1/2=Observed terminal elimination half-life
Time frame: From 1day to 22 days
Chong Kun Dang Pharmaceutical
Industry
A Randomized, Open-label, Single Dose, Two-treatment, Two-period, Two-sequence Crossover Study to Investigate the Effect of Atorvastatin on the Pharmacokinetic Properties of Telmisartan/S-amlodipine After Oral Administration in Healthy Volunteers
Acronym: CKD-345 DDI
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT02839382
Cardiovascular Disease, Cardiovascular Diseases
Seattle, Washington, United States
View Trial DetailsNCT01541943
Cardiovascular Diseases, Dyslipidemias
Seoul, South Korea
View Trial DetailsNCT01842256
Cardiovascular Diseases, Dyslipidemias
Seoul, South Korea
View Trial DetailsNCT07704697
Cardiovascular Diseases, Essential Hypertension
Beijing, Beijing Municipality, China
View Trial Details